A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug
NCT01888445 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2024-10-30
Summary
This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.
Conditions
- Renal Anemia Associated With Chronic Renal Failure (CRF)
Interventions
- DRUG
-
roxadustat
oral
- DRUG
-
darbepoetin alfa
iv
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Medical Director · Astellas Pharma Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-28
- Primary Completion
- 2014-09-15
- Completion
- 2014-09-15
Countries
- Japan
Study Locations
More Related Trials
-
A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia
NCT02780141 ·Status: COMPLETED ·Phase: PHASE3
-
A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) Treatment
NCT02779764 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects
NCT03350347 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects
NCT03350321 ·Status: COMPLETED ·Phase: PHASE3
-
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
NCT02021318 ·Status: COMPLETED ·Phase: PHASE3
-
Maintenance Treatment of Renal Anemia in Dialysis Subjects
NCT03543657 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
NCT02273726 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects
NCT03351166 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.
NCT02174731 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
NCT02912494 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia
NCT05691257 ·Status: UNKNOWN ·Phase: PHASE4
-
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
NCT02052310 ·Status: COMPLETED ·Phase: PHASE3
-
Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia
NCT02791763 ·Status: COMPLETED ·Phase: PHASE3
-
STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
NCT00364845 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
NCT05970172 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
NCT03439137 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia
NCT00563446 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
NCT03402386 ·Status: COMPLETED ·Phase: PHASE3
-
Roxadustat for Anemia in Patients With CKD
NCT04502537 ·Status: UNKNOWN
-
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
NCT04484857 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Study of R744 to Hemodialysis Patients
NCT00491868 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
NCT02969655 ·Status: COMPLETED ·Phase: PHASE3
-
Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
NCT03457701 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease
NCT00121602 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
NCT01977573 ·Status: COMPLETED ·Phase: PHASE2